| CTRI Number |
CTRI/2019/02/017540 [Registered on: 07/02/2019] Trial Registered Prospectively |
| Last Modified On: |
07/02/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
To compare different doses of ketamine given during surgery to find best dose that provides adequate pain relief after the surgery |
|
Scientific Title of Study
|
To compare different doses of intraoperative intravenous ketamine bolus and infusion to determine optimal dose for providing post operative analgesia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Khushbu Goel |
| Designation |
DNB Resident |
| Affiliation |
Batra hospital and medical research center |
| Address |
Department of anaesthesiology,
Batra hospital and medical research centre, 1-Tughlakabad institutional area, Mehrauli Badarpur Road, New Delhi
1-Tughlakabad institutional area, Mehrauli Badarpur Road, New Delhi
South
DELHI
110062
India |
| Phone |
9780472490 |
| Fax |
|
| Email |
khushi7708@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pavan Gurha |
| Designation |
Head of department |
| Affiliation |
Batra hospital and medical research center |
| Address |
Department of anaesthesiology,
Batra hospital and medical research centre, 1-Tughlakabad institutional area, Mehrauli Badarpur Road, New Delhi
1-Tughlakabad institutional area, Mehrauli Badarpur Road, New Delhi
New Delhi
DELHI
110062
India |
| Phone |
9811088632 |
| Fax |
|
| Email |
pavan_gurha@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Khushbu Goel |
| Designation |
DNB Resident |
| Affiliation |
Batra hospital and medical research center |
| Address |
Department of anaesthesiology,
Batra hospital and medical research centre, 1-Tughlakabad institutional area, Mehrauli Badarpur Road, New Delhi
1-Tughlakabad institutional area, Mehrauli Badarpur Road, New Delhi
DELHI
110062
India |
| Phone |
9780472490 |
| Fax |
|
| Email |
khushi7708@gmail.com |
|
|
Source of Monetary or Material Support
|
| Batra hospital and medical research centre |
|
|
Primary Sponsor
|
| Name |
Batra hospital and medical research centre |
| Address |
1,Tughlakabad Institutional Area, Mehrauli Badarpur Road, New Delhi-110062 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Khushbu Goel |
Batra hospital and medical research centre |
Block- B, first floor, Department of anaesthesiology
New Delhi
DELHI |
9780472490
khushi7708@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Scientific research and ethics review committee, Batra hospital and medical research centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ketamine |
Intraoperative intravenous ketamine bolus and infusion |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients Undergoing elective laparoscopic cholecystectomy under general anaesthesia
|
|
| ExclusionCriteria |
| Details |
Patient refusal for inclusion into study group
History of chronic opioid use or opioid abuse
Psychiatric illness / Pregnancy / Morbid obesity
Change from laparoscopic to open technique
Poorly controlled hypertension or diabetes mellitus
Unstable cardiovascular disease
Severe Liver disease or renal disease
Conditions with raised intracranial or intra-ocular pressure
Allergy to study drugs |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Time to extubation
Ramsay Sedation scores
Visual analogue scale score at rest and at movement
Time to first rescue analgesia
Total opioid consumption in 24 hours |
Time to extubation
Ramsay Sedation scores
Visual analogue scale score at rest and at movement
Time to first rescue analgesia
Total opioid consumption in 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Incidence of side effects – nausea, vomiting, delirium, hallucinations
|
in first 24 hours |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/02/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Purpose of study: to determine optimal dose of intravenous ketamine given intraoperatively that provides adequate post operative analgesia with minimal side effects.Background: inadequate post operative analgesia can lead to many complications. Opioids are the most common analgesic agents used but due their many adverse effects many other adjuncts are being investigated. Ketamine is a unique drug that provides analgesia at low doses, so side effects associated with high doses are avoided. Many authors have used different doses and optimal dose is not clear. So we designed this comparative observational study where patients receiving different doses of intraoperative intravenous ketamine will be assessed for their postoperative analgesia requirements in the form of visual analogue scale scoring, time to first rescue analgesia and total opioid consumption in first 24 hours; and incidence of side effects. There will be 4 groups: group A: ketamine bolus of 0.1mg/kg followed by infusion@ 0.25 mg/kg/hr group B: ketamine bolus of 0.2mg/kg followed by infusion@ 0.50 mg/kg/hr group C: ketamine bolus of 0.3mg/kg followed by infusion@ 0.75 mg/kg/hr group D: control group ( will recieve only paracetamol and diclofenac) Patients in all the 4 groups will also receive paracetamol 15 mg/kg and diclofenac 1mg/kg as part of multimodal analgesia. Post operative supplemental analgesia will be provided with diclofenac 1mg/kg 8hourly and rescue analgesia as tramadol 1 mg/kg if visual analogue scale score exceeds 40. |